Parietex TCM1106X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521178847), received between Nov 14, 2017 and Apr 17, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, STRESS, MENTAL ANGUISH, UNABLE TO HAVE INTIMATE RELATIONS, UNABLE TO CONTRIBUTE TO REGULAR DUTIES, SUFFERING, MESH FAILURE, AND ABDOMINAL DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Discomfort; Distress; Emotional Changes; Hernia; Pain; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 21860040 ↗
• InjuryFeb 14, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED LACK OF INCORPORATION, RECURRENCE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Cramp(s) /Muscle Spasm(s); Discomfort; Hernia; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 21385647 ↗
• InjuryMar 26, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, GROIN PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPIC PROCEDURE CONVERTED TO OPEN, LYSIS OF ADHESIONS, AND MESH REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Distress; Emotional Changes; Failure of Implant; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury

  MAUDE report 11577401 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BOWEL OBSTRUCTION/PROBLEMS, RECURRENCE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 11546020 ↗
• InjuryNov 27, 2019Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCARCERATED UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH CONTRACTION, AND MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXCISION OF OLD MESH, REPAIR OF HERNIA WITH MESH. THE PRODUCT HAD BEEN USED WITH AN UNKNOWN TACKER.

  Patient problems: Hernia; Injury

  MAUDE report 9381338 ↗
• InjuryDec 12, 2017Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A SPORTS HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, NERVE ENTRAPMENT, INFLAMMATION, FOREIGN BODY REACTION, CHRONIC AND SEVERE PAIN, SCAR TISSUE, GENITOFEMORAL NEURALGIA, NERVE DAMAGE, ADHESIONS, MESH MIGRATION, AND MENTAL ANGUISH. POST-OPERATIVE PATIENT TREATMENT INCLUDED BILATERAL PELVIC FLOOR REPAIRS, REVISION, AND REMOVAL OF MESH SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Foreign Body Reaction; Inflammation; Injury; Nerve Damage; No Code Available; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 7108049 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN EPIGASTRIC VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BULGING, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL REVISION AND REPAIR OF RECURRENT HERNIA WITH NEW MESH.

  Patient problems: Abdominal Distention; Hernia; Injury; Pain; Unspecified Tissue Injury

  MAUDE report 7027544 ↗